{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T15:07:03Z","timestamp":1764169623619,"version":"3.46.0"},"reference-count":30,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background.<\/jats:title>\n                    <jats:p>Sodium-glucose cotransporter inhibitors (SGLTi) slow chronic kidney disease progression and reduce kidney failure events. Kidney transplant recipients (KTRs) remain at high risk for these outcomes. SGLTi cause an initial and sustained decline in estimated glomerular filtration rate (eGFR) and have a higher risk of urogenital infection, both of which are major concerns for KTRs. We sought to (1) assess the reversibility of eGFR changes and (2) explore safety and tolerability using sotagliflozin, a dual SGLT1\/2 inhibitor.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods.<\/jats:title>\n                    <jats:p>We enrolled stable KTRs in a 16-wk open-label trial of sotagliflozin (12\u2009wk on-drug and 4\u2009wk off-drug) to assess the reversibility of eGFR changes. We assessed whether patient awareness of eGFR changes altered rates of withdrawal by randomizing participants to either (1) unlimited access to all study-related eGFR measurements or (2) limited access, that is, only when eGFR declined to &gt;25% from baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results.<\/jats:title>\n                    <jats:p>\n                      Forty patients were randomized. The mean age was 56\u2005\u00b1\u200515 y; the mean baseline eGFR was 64\u2005\u00b1\u200521\u2009mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      . After 1\u2009wk, change in eGFR from baseline was \u20134.6\u2005\u00b1\u20056.5\u2009mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      (\u20136.9\u2005\u00b1\u20059.5%). After washout, eGFR improved to \u20132.0\u2005\u00b1\u20056.3\u2009mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      (\u20132.4\u2005\u00b1\u200511%), with 73% of patients within 10% of baseline eGFR or higher. Limited versus unlimited access to eGFR measurements did not affect protocol completion (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2005=\u20050.34). Sotagliflozin was generally well tolerated, but 4 patients were withdrawn due to adverse events, with none due to decline in eGFR.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions.<\/jats:title>\n                    <jats:p>Among stable KTRs, sotagliflozin caused an initial decline in eGFR of similar magnitude to patients with chronic kidney disease, with reversibility upon withdrawal. Access to follow-up eGFR measurements did not affect study adherence.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1097\/tp.0000000000005503","type":"journal-article","created":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T04:01:54Z","timestamp":1758600114000},"page":"1887-1895","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Tolerability of Sotagliflozin Among Kidney Transplant Recipients"],"prefix":"10.1097","volume":"109","author":[{"given":"Martina M.","family":"McGrath","sequence":"first","affiliation":[{"name":"Renal Division, Brigham and Women\u2019s Hospital, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Finnian R.","family":"Mc Causland","sequence":"additional","affiliation":[{"name":"Renal Division, Brigham and Women\u2019s Hospital, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian L.","family":"Claggett","sequence":"additional","affiliation":[{"name":"Cardiology Division, Brigham and Women\u2019s Hospital, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew S.","family":"Levey","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Tufts Medical Center, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karela","family":"Herrera-Enriquez","sequence":"additional","affiliation":[{"name":"Renal Division, Brigham and Women\u2019s Hospital, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc A.","family":"Pfeffer","sequence":"additional","affiliation":[{"name":"Cardiology Division, Brigham and Women\u2019s Hospital, Boston, MA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2025,9,23]]},"reference":[{"key":"R1-20251126","doi-asserted-by":"crossref","first-page":"S19","DOI":"10.1016\/j.ajt.2024.01.012","article-title":"OPTN\/SRTR 2022 annual data report: kidney.","volume":"24","author":"Lentine","year":"2024","journal-title":"Am J Transplant"},{"key":"R2-20251126","doi-asserted-by":"crossref","first-page":"2887","DOI":"10.1681\/ASN.2020050566","article-title":"Death after kidney transplantation: an analysis by era and time post-transplant.","volume":"31","author":"Ying","year":"2020","journal-title":"J Am Soc Nephrol"},{"key":"R3-20251126","doi-asserted-by":"crossref","first-page":"729","DOI":"10.1056\/NEJMra2014530","article-title":"Long-term survival after kidney transplantation.","volume":"385","author":"Hariharan","year":"2021","journal-title":"N Engl J 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interventions.","volume":"35","author":"Tong","year":"2022","journal-title":"Transpl Int"},{"key":"R8-20251126","doi-asserted-by":"crossref","first-page":"1358","DOI":"10.1097\/TP.0000000000002125","article-title":"Establishing a core outcome measure for graft health: a Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) Consensus Workshop Report.","volume":"102","author":"Tong","year":"2018","journal-title":"Transplantation"},{"key":"R9-20251126","doi-asserted-by":"crossref","first-page":"e14718","DOI":"10.1111\/ctr.14718","article-title":"Sodium\u2010glucose cotransporter 2 inhibitors for treatment of diabetes mellitus after kidney transplantation.","volume":"36","author":"Lemke","year":"2022","journal-title":"Clin Transplant"},{"key":"R10-20251126","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1186\/s12933-022-01476-x","article-title":"Association of SGLT2 inhibitors with cardiovascular, kidney, and safety outcomes among patients with diabetic kidney 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transplantation.","volume":"378","author":"Chapman","year":"2011","journal-title":"Lancet"},{"key":"R14-20251126","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1016\/j.kint.2023.10.016","article-title":"Executive summary of the KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease: known knowns and known unknowns.","volume":"105","author":"Levin","year":"2024","journal-title":"Kidney Int"},{"key":"R15-20251126","doi-asserted-by":"crossref","first-page":"1887","DOI":"10.1097\/TP.0000000000001774","article-title":"Toward establishing core outcome domains for trials in kidney transplantation.","volume":"101","author":"Tong","year":"2017","journal-title":"Transplantation"},{"key":"R16-20251126","doi-asserted-by":"crossref","first-page":"1875","DOI":"10.1097\/TP.0000000000001776","article-title":"Developing consensus-based priority outcome domains for trials in kidney transplantation.","volume":"101","author":"Sautenet","year":"2017","journal-title":"Transplantation"},{"key":"R17-20251126","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1093\/ndt\/gfad258","article-title":"International consensus on post-transplantation diabetes mellitus.","volume":"39","author":"Sharif","year":"2024","journal-title":"Nephrol Dial Transplant"},{"key":"R18-20251126","doi-asserted-by":"crossref","first-page":"1646","DOI":"10.1111\/dom.15019","article-title":"Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease.","volume":"25","author":"Cherney","year":"2023","journal-title":"Diabetes Obes Metab"},{"key":"R19-20251126","doi-asserted-by":"crossref","first-page":"2632","DOI":"10.1111\/dom.14513","article-title":"Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment.","volume":"23","author":"Cherney","year":"2021","journal-title":"Diabetes Obes Metab"},{"key":"R20-20251126","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1016\/j.kint.2024.06.007","article-title":"Clinical trial designs to assess treatment effects on glomerular filtration rate decline.","volume":"106","author":"Heerspink","year":"2024","journal-title":"Kidney Int"},{"key":"R21-20251126","doi-asserted-by":"crossref","first-page":"e404","DOI":"10.1097\/TP.0000000000004228","article-title":"The efficacy and safety of SGLT2 inhibitor in diabetic kidney transplant recipients.","volume":"106","author":"Lim","year":"2022","journal-title":"Transplantation"},{"key":"R22-20251126","doi-asserted-by":"crossref","first-page":"1954","DOI":"10.1016\/j.ajt.2025.03.019","article-title":"The impact of sodium-glucose cotransporter-2 inhibitors on dialysis risk and mortality in kidney transplant patients with diabetes.","volume":"25","author":"Yen","journal-title":"Am J 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